MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-29 for CHROMID? MRSA 43451 manufactured by Biom?rieux Sa.
[83951643]
A customer from (b)(6) reported to biom? Rieux a false resistant staphylococcus aureus for a nasal specimen in association with chromid? (b)(6) (lot 1005719760). The customer reported there was growth of staphylococcus aureus without gene mec or plp 2. The patient sample was acquired with a nasal swab (eswab) containing transport medium. The specimen showed growth in 24 hours as typical green colonies on (b)(6) plates incubated at 35? C. Test results for the sample: on (b)(6) 2017 - ast with (b)(6) - negative. No diameters were provided by the customer and no pcr performed. The detection of plp2a was performed using immuno-chromatography. The customer reported that no incorrect result was reported to a physician and there was no impact to patient treatment. There was a delay greater than 24 hours for reporting results. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00257 |
| MDR Report Key | 6828649 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-29 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-07-27 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2017-05-23 |
| Date Added to Maude | 2017-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? MRSA |
| Generic Name | CHROMID? MRSA |
| Product Code | JSO |
| Date Received | 2017-08-29 |
| Catalog Number | 43451 |
| Lot Number | 1005719760 |
| ID Number | 03573026136642 |
| Device Expiration Date | 2017-08-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |